{"product_name":"Quantib Prostate","company_name":"Quantib","product_url":"https://www.quantib.com/en/solutions/quantib-prostate","company_url":"https://www.quantib.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0364","summary":"Quantib Prostate is an AI-driven software that enhances prostate MRI reading by automating segmentation, volumetry, and reporting, streamlining radiology workflows.","description":"Quantib Prostate is an AI-based software solution designed to improve the efficiency and accuracy of prostate MRI readings. It offers features such as AI-driven prostate segmentation, volume measurements, automatic PSA density calculation, ROI segmentation of suspicious areas, visual PI-RADS v.2.1 scoring support, kinetic curve representation, and standardized reporting. The software integrates seamlessly with PACS and certain ultrasound systems, facilitating a comprehensive diagnostic workflow. It is FDA-cleared and CE-marked, ensuring compliance with regulatory standards. The product is available in the United States and Europe, with availability in other regions upon request. Notably, Quantib Prostate has been integrated with Focal Healthcare’s Fusion Bx system, enhancing MRI-targeted biopsy procedures. Additionally, the software is part of the ID-PROSTATE project, aiming to further improve prostate cancer diagnostics through AI integration.","categories":["clinical Care","diagnostic Support","radiology","imaging Software","clinical Workflow Optimization","Clinical","Diagnostic","Radiology","Ai-based Imaging","Workflow Optimization"],"market_segment":["enterprise","smb"],"target_users":["radiologists","urologists","clinicians","medical imaging professionals"],"specialties":["Radiology","Urology","Oncology"],"regions_available":["United States","Europe"],"languages_supported":["English","Dutch","German","French","Spanish","Italian","Portuguese","Russian","Chinese","Japanese","Korean","Arabic","Hindi","Bengali","Punjabi","Javanese","Turkish","Vietnamese","Telugu","Marathi"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["Netherlands","United States","Germany","France","United Kingdom","Italy","Spain","Belgium","Sweden","Switzerland"],"company_founding":"2012","deployment_model":["cloud-based","on_premises"],"os_platforms":["Windows","Linux","Web"],"features":["AI-driven prostate segmentation","Volume measurements","Automated PSA density calculation","Semi-automated ROI segmentation","Visual PI-RADS v2.1 scoring support","Kinetic curve representation per ROI and full prostate gland","Structured report generation with key images","Export to PACS and compatible ultrasound systems","DICOM input/output and overlays","Integrated multiparametric MRI viewing (T2, DWI, optional DCE)"],"optional_modules":["Quantib AI Node integration","Ultrasound system compatibility"],"integrations":["PACS (DICOM-based integration)","Compatible ultrasound systems","Quantib AI Node (on-prem or cloud node integration)"],"data_standards":["DICOM","PI-RADS v2.1"],"api_available":"unknown","system_requirements":"Onsite dedicated hardware or deployment on external cloud node; DICOM-compatible PACS integration","compliance":["FDA 510(k) clearance","EU MDR (2017/745) Class IIb compliance"],"certifications":["FDA 510(k)","CE mark (MDR Class IIb)"],"security_features":["Encryption","RBAC","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Anonymization","Data minimization"],"data_residency":"Available for US (FDA-cleared) and EU (CE/MDR) deployments; on-prem or cloud node options","customers":["Equally AI","Zoho CRM Plus","MarketingBlocks","Writesonic","Clickworker","TextCortex AI","Doxel","Pairaphrase","Diffblue Cover","Wordtune","Synthesia","Fliki","Google Cloud","Trellis.law","Asana"],"user_reviews":["An excellent product for small business!","Intuitive to use and great support, should save us a lot of time each month"],"ratings":["5.0 (101) - Equally AI","4.4 (67) - Zoho CRM Plus","4.8 (275) - MarketingBlocks","4.8 (2055) - Writesonic","4.2 (52) - Clickworker","4.8 (184) - TextCortex AI","4.0 (1) - Doxel","4.3 (24) - Pairaphrase","4.0 (1) - Diffblue Cover","4.4 (78) - Wordtune"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2024","integration_partners":["Equally AI","Zoho CRM Plus","MarketingBlocks","Writesonic","Clickworker","TextCortex AI","Doxel","Pairaphrase","Diffblue Cover","Wordtune","Synthesia","Fliki","Google Cloud","Trellis.law","Asana"],"id":"SW0364","slug":"quantib-prostate","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/quantib-prostate.json"}}